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MHRA Inspectorate

Alan Moon

Alan Moon Joined the MHRA in July 2013 as a GMDP Inspector and was promoted to Senior Inspector in 2017. Alan is an Applied Biological Sciences graduate and has inspected in areas including sterile manufacturing, non-sterile manufacturing and investigational medicinal products. Prior to joining the Agency, he worked in the pharmaceutical industry for approximately 20 years in various roles including Quality Control, Quality Assurance and Production.

Manufacture of Investigational Medicinal Products – Frequently Asked Questions

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice, Good manufacturing practice
accurately measuring ingredients into a petri dish

GMP and GCP Inspectors work closely with MHRA Clinical Trials and regularly provide support to help answer a wide range of stakeholder queries which relate to the manufacture, import, labelling, licencing requirements and general handling of Investigational Medicinal Products (IMPs). …

New year, new standards for investigational medicines

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice, Good manufacturing practice

New GMP requirements from 31 January 2022 Monday 31 January 2022 saw the Clinical Trial regulation (CTR) come into force in the European Union, and with it, the Commission guidelines on good manufacturing practice for investigational medicinal products for human …

Annex 16 QP Certification and Batch Release – Frequently Asked Questions – part 2

Posted by: and , Posted on: - Categories: Compliance matters, Good clinical practice, Good manufacturing practice
business woman studying some paperwork

In part 2 of our series on QP Certification and Batch Release we concentrate on the application of Annex 16 to Investigational Medicinal Products (IMPs)

Overview of compliance management escalation processes used by the GMP Inspectorate

Posted by: , Posted on: - Categories: Compliance matters, Events and symposia, Good distribution practice, Good manufacturing practice, Inside the Inspectorate
Iceberg on the horizon

At the GMDP Symposium 2016, Andrew Hopkins and I gave a presentation about the Inspection Action Group (IAG) and Compliance Management Team (CMT), to highlight the systems and processes in place for when compliance issues are identified at manufacturing and …

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This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with.

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